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Friday, July 22, 2011

The Pinnacle Hip recommended for my revision surgery?

Just a brief diversion from the systemic issues for a day. I was shocked when my surgeon recommeded using the Pinnacle hip for my revision. As far as I knew from the press, the Pinnacle hip was about to be recalled! I was perplexed so I started to look into this hip.

(I had to revise this post on the following day 7/23 to clarify these numbers.)

(1) Depuy makes the Pinnacle hip as well as the ASR that was recalled. I was not too happy about that recomendation as I would have preferred to stay away from the Depuy products for now. I am pretty open minded so I began looking into this Pinnacle hip. If I am to go to my surgeon with a NO Pinnacle, my facts better be in order.

(2) There are many types of Pinnacle hips. They are componetized unlike the monoblock (one piece) ASR. That means the surgeon has an option as to to place metal-on-metal, metal on ceramic, metal on plastic, metal on Poly, ceramic on poly etc. My surgeon recommend metal on poly. I am going to ask about the ceramic on poly.

So my first question was what Pinnacle device is the problem in the press? It seems as though the culprit (if there is one) is the Pinnacle 36 MM Ultamet metal-on metal which has been "reported to be failing at high rates." Well, I can surely tell you that there is no way I would put another Metal on metal device in my hip....regardless of who makes it anyway.

(3) I started reviewing the history of the Pinnacle line

Released to the market in 2001 so its been on the market for 10 years.

1 million patients have been implanted with Pinnacles since they were released worldwide

While Depuy reports a clinical success rate of 99.9% reported at 5 years, I don't know what that means for the individual product lines.

Is that success rate for all hips in the pinnacle line?

What hip line does this rate refer to?

Have there been any studies by product line?

(4) I wanted to review the FDA complaints because I had seen this data on the ASR prior to its recall. So, I decided to compare the complaints between the ASR recalled hip prior to their recall and the complaints for the Pinnacle hip, again with the understanding that I don't know what model of Pinnacle the complaints are coupled with but assume they are the MoM mentioned earlier.

Nearly 1300 adverse reports have been filed with the FDA for the Pinnacle hip implants since 2001. In 2010, 545 adverse events were filed (40% of the total).. Most of the reports were filed from 2005-2010. I don't know which Pinnacle hip implant was involved though.

625 adverse reports were filed to the FDA with the Depuy ASR between 2006 and 2009.

It seems that in each case, relative to the number of hip implants each had on the market, the incident numbers reported to FDA seem to be small.

Depuy ASR: 625 problem reports to the FDA over 5 years (US) to 93K on the market world wide (37K in the US.) I would assume the problem reports are US only so it looks like problem complaints totaled about 2% in the US market if my math is right.

Depuy Pinnacle: 1300 problem reports since they have been placed on the market (US) to 1 million on the market world wide. (150K Pinnacles in the US have been placed but I will have to check on those numbers. If 150k is right for the US market, the complaint rate is less than 1% over 10 years.

90% of the Depuy ASR hip complaints required revision. Not sure about the Pinnacles.

I think I would like to see the poster presentation from the AAOS conference in 2007 which makes the claim about the clinical success rate of the Pinnacles over 5 years. I wonder what configuration of the hip was being studied?

I would like to see more information on these Pinnacle devices but I am not as negative as I was when I first heard this recommendation. Seems like it is a device worth considering unless someone else out there has additional information?

I have gone back to reivew the press reports and found that most of the reports are from litigators. Humm? I don;t understand how the problem reports for the Pinnacles over 10 years were relatively low and now there seems to be a plethora of reports (40% of the total incidents to the FDA.) This doesn't make sense. I will check to see if I can get a confirmation on my understanding of these numbers.